The invention relates to surgical instruments for creating a liquid jet and methods for using the instruments in surgical procedures.
Traditionally, many surgical procedures have been performed on patients using open surgical methods that utilize relatively large incisions to expose a surgical field. Many traditional methods have also typically utilized surgical tools such as scalpels, scrapers, blunt dissectors, lasers, electrosurgical devices, etc., which have poor tissue differentiating capability and which can easily cause inadvertent damage to tissue surrounding a surgical treatment site unless carefully utilized. Open surgery with such prior art surgical instruments often involves extensive trauma to the patient, with associated problems of long recovery periods and potential complications.
There has been a trend in recent years to perform many surgical procedures using less invasive techniques by accessing surgical sites via small holes through the skin or through body orifices. These techniques are known as xe2x80x9cminimally invasive surgery.xe2x80x9d Minimally invasive surgical techniques commonly employed include endoscopic, laparoscopic, and arthroscopic surgical procedures. Minimally invasive surgical procedures are commonly preferred to open surgical procedures for many applications because the minimally invasive procedures induce less trauma to the patient during surgery and involve, in many cases, fewer potential complications and reduced recovery time.
A variety of instruments have been developed and utilized for minimally invasive surgical procedures. Frequently used instruments include blades and scalpel-type instruments, motorized rotary blade instruments, laser instruments, and electrosurgical or electrocautery instruments. Typically, these prior art instruments suffer from a variety of disadvantages. For example, the instruments can be slow and laborious to use, typically they lack the ability to selectively differentiate tissue to be excised from non-target tissue, they tend to have sizes and/or shapes which make access of many surgical sites difficult, and they tend to cause unintended damage to tissue surrounding the intended target tissue. Most prior art instruments also require the operator to manually remove excised tissue, for example with forceps, or require an external source of vacuum to be applied to the surgical site, for example via an aspiration tube that is separate from the surgical instrument, in order to remove excised tissue. For applications such as arthroscopy, where visualization of the surgical site is typically effected using an imaging system having a probe such as a fiber optic probe inserted into the surgical site, the above mentioned prior art surgical instruments also typically make it difficult to clearly visualize the site of tissue excision within the surgical field by not effectively evacuating tissue and debris from the surgical site.
Instruments that employ liquid jets have also been utilized in surgical procedures for cutting and ablating tissue. Such instruments have many advantages over the above mentioned surgical instruments for performing both open and minimally invasive surgical procedures. For example, the cutting or ablating power of the liquid jet may be adjusted or controlled by an operator of the instrument, for example by varying the pressure of the liquid supplied to form the jet, to allow for improved tissue differentiation and to reduce inadvertent damage to surrounding tissues when cutting or ablating the target tissue. Liquid jet instruments also can avoid the thermal damage to surrounding tissues that is often caused by instruments such as lasers and electrosurgical devices. In recent years, liquid jet instruments have been utilized for a variety of surgical procedures including open surgical procedures such as liver resection, endoscopic procedures such as kidney stone disruption and removal, and arthrectomy procedures for removal of thrombotic tissue from the vascular system.
U.S. Pat. No. 4,898,574 to Uchiyama et al. describes a variety of lithotomic devices for insertion into a body cavity, which create a fluid jet that is utilized to break up and crush calculi, for example kidney stones, in the body of a patient. The instruments disclosed typically include one or more suction channels for removing fluid and debris. The instruments require that the suction channel be coupled to an external source of vacuum, such as a vacuum pump. The instruments disclosed also typically lack a target or deflector upon which the fluid jet impinges, and, therefore, have the disadvantage of potentially causing unintended damage to healthy tissue by misdirection of the fluid jet.
U.S. Pat. No. 4,913,698 to Ito et al. describes a liquid jet surgical handpiece designed for crushing and removing brain tumors in cerebral surgery. The disclosed instrument includes a liquid jet forming nozzle and a suction tube, which is required to be coupled to an external source of vacuum for removal of the tissue and debris excised by the liquid cutting jet. The liquid jet nozzle is oriented in such a manner that the liquid jet from the nozzle is directed towards a confronting inside wall of the tip of the suction tube when the instrument is in operation in order to prevent the liquid jet from inadvertently damaging a non-target tissue.
U.S. Pat. No. 5,135,482 to Neracher discloses a liquid jet instrument for removing a deposit obstructing a vessel in a human body. The device is configured as a multi-lumen catheter, which includes a pressure resistant duct having a nozzle orifice that creates a supersonic cavitating liquid jet. The liquid jet is directed distally from the instrument to ablate a deposit within a vessel. Some embodiments of the catheter device also include a suction lumen which can be coupled to an external source of vacuum for removing liquid and debris from the vessel. The catheter instruments disclosed do not include a deflector or target element to prevent the liquid jet from potentially impinging upon and causing unintended damage to the vessel or tissue surrounding the deposit to be ablated.
U.S. Pat. No. 5,318,518 to Plechinger et al. disclose a fluid jet instrument configured as a catheter for ablation and removal of a material or deposit from a body vessel or hollow organ. The distal end of the catheter includes a fluid jet nozzle that directs a fluid jet into the mouth of a discharging lumen when the instrument is in operation. The discharging lumen includes a mixing tube and diffuser element. The fluid jet directed into the discharging lumen creates an aspiration force, due to eductor pump action, which serves to transport fluid and ablated material through the discharging lumen without the need for an external source of suction. The mixing tube and diffuser element included in the discharging lumen serve to enhance the aspiration force created by the eductor pump action. The fluid jet can shred or shatter tissue or deposits that lie between the nozzle outlet and the inlet of the discharging lumen, and can drive the shattered particles into the inlet of the discharging lumen for evacuation from the surgical site.
U.S. Pat. No. 5,370,609 to Drasler et al. discloses a fluid jet thrombectomy catheter for removing a thrombus deposit from the cardiovascular system of a patient. The catheter includes a pressure lumen for transporting a high pressure liquid to at least one jet nozzle, and a relatively large bore evacuation lumen for removing liquid and ablated tissue and debris. In operation, the catheter is configured to direct at least one liquid jet into the opening of the large-bore evacuation lumen in a direction that is proximal and coaxial with the evacuation lumen. By directing the jet towards the orifice of the large-bore evacuation lumen of the catheter, a stagnation pressure is induced which can propel fluid and debris proximally for removal.
U.S. Pat. No. 5,527,330 to Tovey discloses a fluid jet cutting and suctioning instrument configured, in some embodiments, for laparoscopic insertion into a patient through a trocar. The instrument includes a body having a handle, an irrigation tube that includes a fluid jet nozzle at its distal end, and an evacuation tube, or in some embodiments a backstop member, positioned to receive the fluid jet. Several of the disclosed embodiments involve an instrument for creating a fluid jet that is directed transversely to a longitudinal axis of the body of the instrument. In one embodiment, the instrument includes a sliding sheath element that is able to move the irrigation tube and suction tube laterally with respect to each other to adjust the gap between the fluid jet forming nozzle and the inlet of the suction tube so as to change the length of the fluid cutting jet, when the instrument is in operation. The instruments described by Tovey have several disadvantages for use in many minimally invasive surgical procedures. For example, the shape and design of the irrigation and suction tubes requires the instrument to be relatively bulky and have a cross-sectional dimension and shape that is ill suited for inserting the instrument into confined regions of the body for performing many minimally invasive surgical procedures. In addition, the instruments disclosed are designed so that an external source of suction must be coupled to the suction tube in order to evacuate fluid and ablated tissue from the surgical site.
While the above mentioned surgical liquid jet instruments represent, in some instances, significant improvements over many prior art surgical instruments for performing open and minimally invasive surgical procedures, there remains a need in the art to provide simple, inexpensive, liquid jet surgical instruments which have improved cutting, ablation, and tissue evacuation capabilities, and which have the ability to be utilized in a wide variety of open and minimally invasive surgical procedures. The present invention provides, in many embodiments, such improved surgical liquid jet instruments, and further provides methods for their use in a variety of surgical procedures.
The present invention provides a series of devices related to surgical procedures utilizing liquid jets for cutting, ablating, sculpting, trimming, etc., tissues and/or materials from the body of a patient. The invention includes, in one aspect, a series of devices comprising surgical liquid jet instruments for forming a liquid jet, in another aspect, methods for using the surgical liquid jet instruments, and, in yet another aspect, methods for forming certain components of the surgical liquid jet instruments.
In one aspect, the invention provides a series of surgical liquid jet devices. One device comprises a surgical instrument for use in a gaseous or liquid environment having a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that is adapted to be controllable by an operator. The instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen that includes a jet-receiving opening that has a cross-sectional area. The jet-receiving opening of the evacuation lumen is locatable opposite the jet opening at a predetermined distance therefrom to receive a liquid jet when the instrument is in operation. The nozzle is shaped to form a liquid jet as a liquid at high pressure flows therethrough. The liquid jet creates an entrainment region of moving liquid such that essentially all of the moving liquid in the entrainment region is directed into the jet-receiving opening when the instrument is in operation. In addition, the cross-sectional area of the jet-receiving opening and the predetermined distance between the jet opening and the jet-receiving opening are selected so that the entrainment region occupies between 50% and 100% of the cross-sectional area of the jet-receiving opening when the instrument is in operation.
Another device comprises a surgical instrument that has a distal end adapted to perform a surgical procedure on a patient and a proximal end including a body. The body includes a grasping region that is shaped and positionable to be held by the hand of an operator. The instrument includes a pressure lumen that has sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument and includes at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen, supported by the body, that includes a jet-receiving opening locatable opposite the jet opening at a predetermined distance therefrom to receive a liquid jet when the instrument is in operation. The distal end of the surgical instrument has a predetermined contour and size that is selected to facilitate insertion of the distal end of the surgical instrument into a confined region of a body defining a surgical operating space for a specific surgical procedure.
Yet another device comprises a surgical instrument that has a distal end adapted to perform a surgical procedure on a patient and a proximal end including a body. The instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening. The surgical instrument is constructed and arranged to be entirely disposable after a single use.
Another device comprises a surgical instrument that has a distal end adapted to perform a surgical procedure on a patient and a proximal end including a body. The body has a grasping region that is shaped and positionable to be held by the hand of an operator. The instrument includes a pressure lumen having a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument. The pressure lumen includes at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen having a jet-receiving opening locatable opposite the jet opening at a predetermined distance therefrom to receive a liquid jet when the instrument is in operation. At least one nozzle included in the instrument comprises a hole in the side wall of a lumen.
Yet another device comprises a surgical instrument having a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that is adapted to be controllable by an operator. The instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen including a jet-receiving opening locatable opposite the jet opening at a predetermined distance therefrom to receive a liquid jet when the instrument is in operation. The nozzle is shaped to form a liquid jet as a liquid at high pressure flows therethrough, and the liquid jet is directed into the jet-receiving opening when the instrument is in operation. The evacuation lumen includes a region that is within and/or downstream of the jet-receiving opening. The evacuation lumen is shaped and positionable so that a liquid within the region is able to macerate at least a portion of a tissue entrained in the liquid into a plurality of particles when the instrument is in operation.
Another device comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that includes a body. The body has a grasping region that is shaped and positionable to be held by the hand of an operator. The instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen that is supported by the body and that includes a jet-receiving opening locatable opposite the jet opening to receive a liquid jet when the instrument is in operation. At least a portion of the pressure lumen and/or evacuation lumen is rotatably moveable relative to the other for adjusting the separation distance between the jet opening and the jet-receiving opening.
Yet another device comprises a surgical instrument that has a distal end adapted to perform a surgical procedure on a patient and a proximal end that includes a body. The body has a grasping region that is shaped and positionable to be held by the hand of an operator. The instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that has a distal end including at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen supported by the body that includes a jet-receiving opening, which is locatable opposite the jet opening to receive a liquid jet when the instrument is in operation. The distal end of the pressure lumen is shaped to enable the jet opening to be positionable adjacent to a surface to be ablated or debrided such that a liquid jet emanating from the jet opening is separated from the surface by a distance essentially equal to a wall thickness, at the jet opening, of tubing comprising the pressure lumen.
Another device comprises a surgical instrument that has a distal end adapted to perform a surgical procedure on a patient and a proximal end that includes a body. The body includes a grasping region that is shaped and positionable to be held by the hand of an operator. The instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen that has a proximal end and a distal end. The distal end of the evacuation lumen includes a jet-receiving opening that is locatable opposite the jet opening at a predetermined distance therefrom to receive the liquid jet when the instrument is in operation. The evacuation lumen is shaped and positionable to enable evacuation of essentially all of the liquid comprising the liquid jet from the jet-receiving opening to the proximal end of the evacuation lumen without the need of an external source of suction.
Yet another device comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that includes a body. The body includes grasping region that is shaped and positionable to be held by the hand of an operator. The body includes at least two actuating elements, where each of the at least two actuating elements is adapted to be actuatable by a single hand of an operator holding the grasping region. Each actuating element causes an essentially identical predetermined change in a function, shape, position, or orientation of at least a portion of the distal end of the instrument upon actuation of the element.
Yet another device comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure in a patient and a proximal end that includes a body. The body includes a grasping region that is shaped and positionable to be held by the hand of an operator. The body includes at least one actuating element that is adapted to be actuatable by a single hand of an operator holding the grasping region. The actuating element is shaped and positionable on the body to enable the operator to hold the body in one of at least two hand/grasping region orientations with a single hand and to effect an essentially identical predetermined change in a function, shape, position, or orientation of at least a portion of the distal end of the instrument, upon actuation of the element, when holding the body in either of the at least two hand/grasping region orientations.
Yet another device comprises a surgical instrument that has a distal end to perform a surgical procedure on a patient and a proximal end adapted to be controllable by an operator. The instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen that has a proximal end and a distal end and a jet-receiving opening near its distal end that is locatable opposite the jet opening to receive a liquid jet when the instrument is in operation. The evacuation lumen has an internal cross-sectional area which increases essentially continuously from a minimum value at the jet-receiving opening to a maximum value at a predetermined position proximal of the jet-receiving opening. This maximum value is essentially constant at positions proximal to the predetermined position.
Another device comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that is adapted to be controllable by an operator. The instrument includes a pressure lumen comprising a tubular conduit having a distal end and a proximal end. The pressure lumen has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument. The distal end of the tubular conduit has a necked region with a reduced cross-sectional dimension that is less than a cross-sectional dimension of the tubular conduit outside of and proximal to the necked region. The necked region comprises a nozzle that includes a jet opening and is shaped to enable the jet opening to form a liquid jet when a high pressure liquid flows therethrough. The nozzle is oriented so that at least a central region of the liquid jet is directed essentially perpendicular to a longitudinal axis of the conduit outside the necked region. The nozzle is also shaped so that essentially no portion of the jet opening projects radially beyond a perimeter defined by an outer surface of the tubular conduit in a region adjacent to the nozzle but outside the necked region.
In other embodiments, the invention provides devices specifically for use in a gaseous environment. In one such embodiment, the invention provides a device for use in a gaseous environment comprising a surgical instrument that has a distal end adapted to perform a surgical procedure on a patient and a proximal end that is adapted to be controllable by an operator. The instrument includes a pressure lumen having a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen that has a jet-receiving opening that is locatable opposite the jet opening at a predetermined distance therefrom to receive a liquid jet when the instrument is in operation. The nozzle is shaped to form a liquid jet as a high pressure liquid flows therethrough. The liquid jet comprises a diverging region of liquid droplets moving through the gaseous environment, with the diverging region having an apex located at the jet opening, such that essentially all of the moving liquid droplets in the diverging region are directed into the jet-receiving opening when the instrument is in operation.
Another device for use in a gaseous environment comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that is adapted to be controllable by an operator. The instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen that has a proximal end and a distal end. The distal end of the evacuation lumen includes a jet-receiving opening that is locatable opposite the jet opening at a predetermined distance therefrom to receive the liquid jet when the instrument is in operation. The evacuation lumen is shaped and positionable to enable evacuation of essentially all of the liquid comprising the liquid jet from the jet-receiving opening to the proximal end of the evacuation lumen without the need for an external source of suction.
Yet another device for use in a gaseous environment comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end adapted to be controllable by an operator. The instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that has a distal end including at least two nozzles, where each nozzle provides a jet opening. Each nozzle is shaped to form a liquid jet as a liquid at high pressure flows therethrough. The instrument further includes an evacuation lumen that has a distal end including a jet-receiving opening that is locatable opposite at least one of the jet openings at a predetermined distance therefrom. The predetermined distance between the at least one jet opening and the jet-receiving opening defines a gas-filled gap between the jet opening and the jet-receiving opening. The jet-receiving opening is shaped and positionable to receive at least one liquid jet when the instrument is in operation.
Yet another device for use in a gaseous environment comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that is adapted to be controllable by an operator. The instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen that has a jet-receiving opening locatable opposite the jet opening at a predetermined distance therefrom to receive a liquid jet when the instrument is in operation. The nozzle is shaped to form a liquid jet as a liquid at high pressure flows therethrough, and the liquid jet is directed across a gas-filled gap and into the jet-receiving opening when the instrument is in operation. The nozzle and the jet-receiving opening are shaped and positionable relative to each other so that back-flow of a liquid mist or spray from the jet-receiving opening into the gas-filled gap is essentially eliminated when the instrument is in operation.
Another device for use in a gaseous environment comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that is adapted to be controllable by an operator. The instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening. The instrument further includes an evacuation lumen including a jet-receiving opening that is locatable opposite the jet opening at a predetermined distance therefrom to receive a liquid jet when the instrument is in operation. The nozzle is shaped to form a liquid jet as a high pressure liquid flows therethrough. The liquid jet is directed across a gas-filled gap and into the jet-receiving opening when the instrument is in operation. The nozzle and the jet-receiving opening are shaped and positionable relative to each other so that a cross-sectional shape and area of the liquid jet at a given location within the evacuation lumen is essentially the same as an internal cross-sectional shape and area of the evacuation lumen at the same given location. The given location comprises the jet-receiving opening and/or a location proximal to the jet-receiving opening.
In yet another aspect, the invention provides methods for utilizing a surgical liquid-jet instrument. In one embodiment, the invention provides a method comprising inserting a surgical liquid-jet instrument into a joint capsule of a patient, creating a liquid jet with the surgical liquid-jet instrument, directing the liquid jet towards a jet-receiving opening in an evacuation lumen of he surgical liquid-jet instrument, and cutting or ablating a selected tissue within the joint capsule with the liquid jet.
In another embodiment, the invention provides a method comprising positioning a surgical liquid-jet instrument in close proximity to a surface of a body of patient, creating a liquid jet in a surrounding gaseous environment with the liquid-jet instrument, directing the liquid jet essentially tangential to the surface and towards a jet-receiving opening in an evacuation lumen, debriding a material from the surface with the liquid jet, and evacuating a liquid comprising the liquid jet and the debrided material from the jet-receiving opening to a proximal end of the evacuation lumen without the need for an external source of suction.
In yet another aspect, the invention provides a method for forming a jet nozzle region in a tube. The method comprises necking down an end of a tube providing a lumen to form a jet nozzle region in the tube that has a reduced cross-sectional dimension. The method further comprises offsetting the jet nozzle region from being essentially co-linear with an axial center line of the tube outside the jet nozzle region to a position where an axial center line of the jet nozzle region is displaced from the axial center line of the tube outside the jet nozzle region by a distance of about d=Rxe2x88x92r, where R is the internal radius of the tube outside the jet nozzle region and r is the internal radius of the jet nozzle region.
Other advantages, novel features, and objects of the invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings, which are schematic and which are not intended to be drawn to scale. In the figures, each identical or nearly identical component that is illustrated in various figures is represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention.